The rotary therapy selector switch may fail, resulting in unexpected device behavior. These behaviors include: The device may not turn on; The device may not perform the selected function;…
Warnings statements have been added- exceeding 40 degree C for extended periods may cause tissue damage. Additionally, a caution was added and clarifications were made regarding the use of…
Class IIFDA: TerminatedCincinnati Sub-Zero Products LLC, a Gentherm Company
Bent transfer catheter tips may cause difficulty or inability in inserting the transfer catheter into the guiding catheter. Potential adverse events that may occur if an affected product is…
Removal of claims for N-proBNP in the Liquid Cardiac Control catalogue number CQ5053 due to an observed decrease in recovery for N-Terminal Pro-Brain Natriuretic Peptide (NT-proBNP) in…
Class IIFDA: TerminatedRandox Laboratories, Limited
Warnings statements have been added- exceeding 40 degree C for extended periods may cause tissue damage. Additionally, a caution was added and clarifications were made regarding the use of…
Class IIFDA: TerminatedCincinnati Sub-Zero Products LLC, a Gentherm Company
The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
Class IIFDA: TerminatedCook Inc.
How to use this monthly recall archive
Use this page to compare the recalls reported during the month, then open an individual record for the exact reason, classification, company, remedy or distribution information available from the official source. Monthly counts are descriptive, not a safety rating.